Relapses reduced by 67% after 72 months with ozanimod in patients with multiple sclerosis

Key takeaways:

• Three- and 6-month confirmed disability progression occurred in 17.2% and 15.2% of participants at 72 months.
• One researcher called the results “promising” for patients with MS.

WEST PALM BEACH, Fla. — In an open-label extension, treatment with ozanimod demonstrated sustained efficacy for disease progression in patients with relapsing multiple sclerosis, per research presented at ACTRIMS 2024.

“Given MS is progressive and irreversible in nature with no cure, it is imperative to understand patients’ long-term treatment responses to assist in the clinical decision-making process, with the goal of stopping disease progression and improving outcomes,” Jonathan Sadeh, MD, MSc, senior vice president and head of Immunology, Cardiovascular and Neuroscience at Bristol Myers Squibb, told Healio in an email.

Sadeh and colleagues sought to provide an update on safety and efficacy of extended exposure to ozanimod (Zeposia, Bristol Myers Squibb), an oral sphingosine 1-phosphate receptor 1 and 5 modulator, for those with relapsing forms of MS.

Their analysis of the DAYBREAK open-label extension included 2,494 individuals who completed phase 1 to 3 clinical trials featuring ozanimod, given 0.92 mg per day of the novel therapy and who registered a mean exposure range of 60.9 months. Annualized relapse rate (ARR) was calculated by utilizing negative binomial regression pooled for all parent trial treatment groups. New or enlarging T2- and gadolinium-enhancing (GdE) lesions were reported for patients who entered DAYBREAK from active-controlled phase 3 trials, up to Apr. 7, 2023.

According to results, at month 72 of DAYBREAK, 67% of participants were relapse-free, while 3- and 6-month confirmed disability progression occurred in 17.2% and 15.2% of patients, respectively.

At month 60, adjusted mean number of new/enlarging T2 lesions per scan (range: 0.789-0.932) and adjusted mean number of GdE lesions (0.062-0.077) were similar, regardless of treatment in a parent trial.

Data further showed 89% of participants recorded any treatment-emergent adverse events (TEAEs); 15.3% logged a serious TEAE (SAE) and 3.9% discontinued due to a TEAE.

The most common TEAEs were nasopharyngitis (21.3%), headache (17.1%), COVID-19 infection (16.5%) and upper respiratory tract infection (12.4%), numbers similar to those in parent trials, excluding COVID-19.

“Two-thirds of patients with relapsing forms of MS receiving Zeposia were relapse-free at 6 years and no new safety signals emerged in this long-term study,” Sadeh told Healio. “These findings are very promising and strengthen our confidence in the role of Zeposia as a safe and effective treatment option for long-term management of patients with MS.”